Robert
Hoover, MD
Michael
Hammes

Sunrise Hires Former DMERC Medical Director
Sunrise Medical, Carlsbad, Calif, has appointed Robert Hoover, MD, as senior vice president of global clinical services. Using his clinical expertise, Dr Hoover will work to further ensure that the company and the health care community are true partners in their goals and efforts.

“We strongly believe that having a focused effort, and really partnering with providers, physicians, clinicians, and the associations, will positively influence what we are doing at Sunrise and ultimately advance our knowledge of how to do it better with all stakeholders in mind,” said Michael Hammes, Sunrise chairman and CEO.

Spending the last 7 years at the Bloomfield, Conn-based insurer CIGNA as the Durable Medical Equipment Regional Carrier (DMERC) Medical Director for Region D, Hoover brings an abundance of medical knowledge and professional relationships to his new job at Sunrise.

“Part of my role is [to look at] what best serves the beneficiary and meets their medical needs,” Hoover said. “As always, Sunrise will look at product development with an eye towards making the right product that meets the needs of the patient. This is a unique opportunity to help Sunrise Medical develop innovative products that meet the clinical needs of patients based upon sound scientific research and outcomes measures.”
Hans Rudolph Quality System Obtains ISO Certification
The Full Quality Management & Quality Assurance System from Hans Rudolph Inc, Kansas City, Mo, complies with and has been certified and registered to the following legislation and standards: ISO 9001:2000, ISO 13485:2003 CMDCAS (Canadian Medical Devices Regulations). The registration is subject to the company maintaining its quality system to the required standards, which are monitored and audited semiannually. The Hans Rudolph product line also carries the CE Mark Registration requirement for shipping to European countries.
Respironics Enters Into Agreement With Westmed
Respironics Inc, Murrysville, Pa, has entered into an asset purchase agreement with Westmed Inc, Englewood, Colo, a US manufacturer of both respiratory and anesthesia disposables, for the sale of its BagEasy® line of manual resuscitators. Upon closing the agreement, Westmed plans to relocate manufacturing of the BagEasy product to its facility in Tucson, Ariz. Arrangements are in place between the two companies to minimize any interruption in the production and sale of the BagEasy products during the transition period.
FDA Approves ROZEREM
Takeda Pharmaceuticals North America Inc, Lincolnshire, Ill, recently announced that the US Food and Drug Administration (FDA) approved the New Drug Application for ROZEREM™ (ramelteon) 8-mg tablets for the treatment of insomnia characterized by difficulty with sleep onset. The FDA approval allows physicians to prescribe ROZEREM for long-term use in adults. ROZEREM has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the US Drug Enforcement Administration.“People with insomnia are not only affected by their sleeplessness at night; insomnia’s impact is also in how they feel and function the next day,” said Thomas Roth, PhD, director of the Sleep Disorders and Research Center, Detroit. “Current therapies often used for insomnia work by broadly inhibiting the activity of neurons in the brain. Ramelteon treats insomnia by specifically affecting the activity of neurons in an area of the brain involved in the sleep-wake process, and has been shown to carry no risks of abuse, withdrawal, or dependency, and negligible risk for next-day ‘hangover’ effects.”
ResMed Splits Stock
The Board of Directors of ResMed Inc, San Diego, has approved a two-for-one split of its common stock, payable in the form of a 100% stock dividend. Shareholders of record will receive one additional share of common stock for every share held on September 15, 2005.“ResMed’s share price has appreciated over 90% since our last split in March of 2000, reflecting strong financial performance from the company and robust growth in the industry at large,” said Peter C. Farrell, PhD, chairman and CEO. “We hope this stock split will further increase the liquidity of our shares and make them more appealing to individual investors.”

The common stock will be distributed on or about September 30, 2005, by ResMed’s transfer agent, American Stock Transfer and Trust Company. On August 9, 2005, ResMed had common stock outstanding of approximately 36 million shares. Following the stock distribution, the number of outstanding shares will increase to approximately 72 million.
SleepTech Solutions Founder Named to NSF Board
The National Sleep Foundation (NSF), Washington, DC, recently appointed Vyto Kab, founder of SleepTech Solutions, Kinnelon, NJ, to its board of directors. Vyto Kab

“Vyto Kab presents a strong and well-respected figure with over 12 years as a pioneer in the sleep field, and will be a valuable asset to our group,” said James K. Walsh, PhD, NSF’s director and former chair.

Other directors named to the board include Thomas Balkin, PhD, of the Walter Reed Army Institute of Research; Christopher Drake, PhD, of the Henry Ford Hospital Sleep Disorders and Research Center in Detroit; Michael Vitiello, PhD, of the University of Washington, Seattle; Lorraine Wearley, PhD, an independent management consultant; and Franklin K. Willis, Esq, Lynn Health Science Institute in Oklahoma City. The board also voted unanimously to elect Barbara Phillips, MD, MSPH, NSF chair, succeeding Walsh, who will continue to serve as a director.
Facing Lower Earnings Invacare Reduces Staff
Making adjustments for recent lower than anticipated earnings, Invacare Corp, Elyria, Ohio, completed its first round of layoffs, reducing its staff by 36 in a series of layoffs that are expected to total 230. According to a recent sales and earnings press release statement by A. Malachi Mixon III, chairman and CEO of Invacare, the staff decrease is part of cost reduction and profit improvement actions that also include outsourcing improvements using Chinese manufacturing and third parties, shifting substantial resources from product development to manufacturing cost reduction activities and product rationalization, reducing freight exposure through freight auctions and changing the freight policy, general expense reductions, and exiting four facilities. A. Malachi Mixon III

“As a result of these actions,” Mixon said, “the company anticipates recognizing a $3 million to $5 million charge in the third quarter of this year. These initial actions are expected to result in annualized savings of $20 million as Invacare enters 2006.”

Invacare’s financial results for the second quarter and first half of the year ended June 30, 2005 were in range with recent guidance. Earnings per share for the second quarter were $0.40 versus $0.56 for the second quarter last year, while net earnings for the quarter were $12.9 million versus $18.0 million for the second quarter last year. While these numbers were down, net sales for the quarter did increase 17% to $396.3 million versus $339.3 million for the second quarter last year. Foreign currency accounted for three percentage points of the net sales increase, while acquisitions contributed an additional 11 percentage points for the quarter. The quarter’s higher net sales were offset by a lower gross margin; higher selling, general and administrative expense (SG&A expense); and higher interest expense.
Sunrise Expands US Delivery
Sunrise Medical, Longmont, Colo, has opened a new distribution center. Located in High Point, NC, it marks the second new Sunrise distribution center to open in the last 5 months and is part of a 13-month expanded distribution center strategy that will increase Sunrise’s overnight delivery coverage in the United States from 30% to more than 80%. Part of the Sunrise overall distribution plan is to accommodate same-day customer “will call” orders. Will-call provides customers with a new level of service and was developed to ensure that their need for immediate product is addressed. The new distribution center features a drive-up ramp for added will-call order convenience and will be managed by Philip Welch.
SLP Launches New Website
A new Website from SLP Inc, St. Charles, Ill, makes it easier to find information about bruxism and SLP’s BiteStrip device, used to identify the existence and frequency of this disorder. The site, www.bitestrip.com, includes bruxism diagnosis information, educational materials, a video, an FAQ section, a power-point presentation, and supportive clinical information. SLP also plans to add a consultation corner to allow people to submit questions about bruxism and BiteStrip.
Cephalon’s PROVIGIL Tested for Treatment of Shift Work Sleep Disorder
Cephalon Inc, Frazer, Pa, recently announced that results of its pivotal phase three study of PROVIGIL in patients with shift work sleep disorder (SWSD) have been published in the New England Journal of Medicine. In the clinical study of SWSD, patients taking PROVIGIL showed improvements in their wakefulness, performance, and level of attention. “This study further clarifies the role excessive sleepiness plays in shift work sleep disorder, and the value of PROVIGIL in treating excessive sleepiness,” said Dr Paul Blake, executive vice president, Worldwide Medical and Regulatory Operations at Cephalon.Key results of the study show that:

  • PROVIGIL significantly improved patients’ level of alertness when measured objectively, as compared to patients treated with a placebo;
  • PROVIGIL significantly reduced patients’ level of sleepiness when measured subjectively, as compared to patients treated with a placebo;
  • Patients treated with PROVIGIL had a significant reduction in the number and duration of lapses of attention during 20-minute computerized tests conducted in a sleep laboratory, as compared to patients treated with a placebo;
  • A higher percentage of patients treated with PROVIGIL (74%) were rated as improved using the physician-rated Clinical Global Impression of Change scale, as compared to patients treated with a placebo (36%).

“This is a very important first study demonstrating the value of an effective therapy for shift work sleep disorder and illustrates the need for further research to identify other effective therapies for these patients, whose sleepiness was not completely resolved with treatment,” said Charles A. Czeisler, PhD, MD, lead study author and professor of sleep medicine at Harvard Medical School.
Peter C. Farrell, PhDResMed Releases Record Financial Results
ResMed Inc, San Diego, reported record revenue and income results for the quarter and year ended June 30, 2005. Revenues for the June 30, 2005 quarter were $125.4 million, a 35% increase over the quarter ended June 30, 2004. Excluding the incremental revenue contribution from acquisitions, revenue was $116.4 million, an increase of 25%. Company revenues for fiscal year 2005 were $425.5 million, an increase of 25% over the year ended June 30, 2004. Excluding the incremental revenue contribution from acquisitions, revenue was $414.0 million, an increase of 22%. “Fiscal 2005 was another successful year for ResMed, and our financial results certainly reflect that,” said Peter C. Farrell, PhD, ResMed chairman and CEO. “The launch of the Mirage Swift patient interface, the acquisition of Saime, and the roll-out of the new S8 platform have delivered strong revenue and profit results this year and, more importantly, have positioned us well for further growth.”